March/April 2006
Volume 26, Number 2

Theme: Equipment/Direct Impact Systems

Table of Contents

Articles

Safety Evaluation of a Flexible Engineering Control System
by Tony O’Connell, Marie Coggins, Victoria Hogan, and Miriam Byrne
This article presents a study performed to evaluate the fitting, removal, and disposal of contaminated filter cartridges using a flexible containment system.
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Laboratory Instrument Qualification: Solving the Puzzle
by Jason C. Fitz
This article presents the process of qualifying laboratory instruments. It provides documentation needs, categorization suggestions, testing approaches, and resource requirements necessary for a successful program. The article begins with instrument design and purchasing, covers installing and qualifying, and discusses the support systems that maintain the instrument in a qualified state throughout its life.
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Large-Scale Chromatography Becoming State-of-the-Art
by Roy Greenwald and Bill Rochelle
This article describes the process, design, and fabrication considerations to take into account for large-scale chromatography control and dilution equipment.
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Energy Saving Tips for Designing Air Handling Units (AHUs) in Cleanrooms
by Xingyun Mao
This article provides recommendations for designing Air Handling Units (AHU) that will improve system operation and performance.
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Equipment Cleaning Validation Modeling Approach for Clinical Trial Compounds
by Lisa Ray, Dr. Brian Pack, Dr. Lisa Wenzler, and Travis Coy
This article outlines the theory and implementation of the equipment cleaning validation strategy in Clinical Trial Packaging at Eli Lilly and Company using model compounds, and describes the process for managing the equipment cleaning validation program.
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Aseptic Filling of Closed, Ready to Fill Containers
by Jacques Thilly, Doris Conrad, and Christian Vandecasserie
This article presents a closed vial filling technology. It details the vial and stopper design, manufacturing, the e-beam surface sterilization unit, the filling equipment and process, and sealing laser technology.
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Interview with Norikazu Eiki, President and Representative Director, Bayer Yakuhin, Ltd.
by Joe Phillips, Shinichi Osada, and Gloria Hall
This article presents a closed vial filling technology. It details the vial and stopper design, manufacturing, the e-beam surface sterilization unit, the filling equipment and process, and sealing laser technology.
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Operational Qualification (OQ) Testing of Integrated, Automated Systems
by Poul Grav Petersen
This article describes the challenges in planning, executing, evaluating, and reporting OQ activities upon a brief introduction to OQ for automated systems.
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The Power of Planning and how it Translates to Commissioning Efforts
by Katie Henchir
This article explores one planning approach for commissioning efforts that divides planning into four categories.
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Departments

ISPE Update
New Products and Literature
Classified Advertising